批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2024/06/05 |
SUPPL-85(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/05/28 |
SUPPL-79(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/04/25 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/11/20 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/06/12 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/06/16 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/11/14 |
SUPPL-41(补充) |
Approval |
Labeling |
|
|
|
1994/02/08 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
|
1991/08/07 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/28 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/29 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/09/09 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/09/09 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/11/23 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/11/23 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/03/29 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/01/16 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/11/22 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/09/07 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/09/07 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/11/12 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
084122 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
HIKMA |
085162 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
088832 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1985/12/04
|
MYLAN |
089247 |
003 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1985/12/04
|
SUN PHARM INDUSTRIES |
040362 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2001/08/29
|
JUBILANT CADISTA |
040256 |
002 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2002/07/12
|
ENDO OPERATIONS |
210525 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2018/12/04
|
GENEYORK PHARMS |
211575 |
003 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/11/15
|
NOVITIUM PHARMA |
213386 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/06/24
|
AMNEAL |
208412 |
001 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/02/11
|
STRIDES PHARMA |
215672 |
003 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/03/28
|
AUROBINDO PHARMA LTD |
212629 |
002 |
ANDA |
PREDNISONE |
PREDNISONE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2023/12/05
|
ALLIED |